Department of Pharmacology and Therapeutics Postgraduate ... · PG Dip/MSc Pharmaceutical Medicine Prospectus 2019 Year 2 Module 7: PM7020 - Medicines Regulation (Term 1)** Module

Department of Pharmacology and Therapeutics

Postgraduate Diploma/MSc in

Pharmaceutical Medicine

2019–2021 prospectus

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PG Dip/MSc Pharmaceutical Medicine Prospectus 2019

Index

Introduction .........................................2

Key Features of the course....................2

Intended Participants ...........................2

Course Structure ..................................3

Course Content and Timetable .............4

Course Venue .......................................8

Course Materials ..................................8

Fees .....................................................8

Course Faculty ......................................9

Further Information ........................... 11

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Introduction

These established courses have been designed to improve the knowledge and skills of healthcare professionals in the area of pharmaceutical medicine. It provides comprehensive information to enable students acquire a proper understanding of each topic covered in the course. It looks at each topic from a European and international perspective and therefore is designed to cater for the needs of EU and non-EU students.

The course is aimed at the broad range of health science professionals working in the pharmaceutical healthcare area. The module content is in line with the current syllabus of the Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the United Kingdom. Trinity is a member of the PharmaTrain Federation. These courses have been accredited by PharmaTrain and Trinity has been designated as a PharmaTrain Centre of Excellence for pharmaceutical medicine training.

Key Features of the course:

It provides suitably qualified healthcare professionals with specialist knowledge and skills in all aspects of pharmaceutical medicine

It enables graduates to assume positions in, or extend their current role within the pharmaceutical industry, regulatory authority and other relevant areas within the healthcare system

Engages teaching and educational support from academic staff members of the Faculty of Health Sciences, Trinity, experts from the National Centres for Pharmacoeconomics and Medicines Information, and experts from national and international regulatory authorities and pharmaceutical organisations.

Intended Participants

Prospective students for the postgraduate diploma and MSc should hold a primary honours degree in either medicine or another relevant health science subject. Candidates should have a minimum of 2 years’ practical experience in their area of qualification/pharmaceutical industry. Candidates from within and outside the EU will be eligible for enrolment onto each course, providing their primary degree is from a recognised institution and of equivalent grading.

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Course Structure

Both courses are part-time and will be run together.

Postgraduate Diploma Programme

The course is a taught programme, run over 18 months for a total of 12 modules. Each module is typically for 3 days and consists of a combination of formal teaching sessions, workshops and interactive / practical sessions. Pre-module reading lists will be provided and will form part of the module teaching. Two of the modules will be undertaken by way of blended learning. Course materials will be circulated electronically for the distance learning modules. In addition all registered students will have access to a web-based virtual learning environment facility. Students will be expected to interact with other class members and the course co-ordinators via the e-learning platform.

Completion of each module is obligatory. Students are recommended to attend all of the taught modules, but must attend at least 10 of the 12 face-to-face modules.

Assessment will consist of personal assignments (continuous assessment) and written examinations. Continuous assessment assignments must be completed by the students for each module and submitted at designated time points. Students must submit continuous assessment assignments for all modules.

MSc. Programme

Students must complete the postgraduate diploma course modules, as outlined above. In addition, students will be assigned a research project (in primary research), which should be submitted as a dissertation (with the possibility of an oral examination) by the 31st August of the second year, unless an extension is granted by the Faculty.

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Course Content and Timetable

Year 1

Module 1: PM7011 - Introductory Programme: Principles of Discovery of Medicines and Development Planning (Sept 2019)

Module Overview:

This module introduces the aims and objectives of the course. It discusses the principles of pharmaceutical medicine. It describes the philosophy behind new drug development and how this impacts on the activity of a pharmaceutical company. It describes the various factors which have an impact on the life-cycle of a drug.

Module 2: PM7013 - Exploratory and Confirmatory Clinical Development (Term 1)*

Module Overview:

The aim of this module is to provide a comprehensive overview of the main types of studies used in clinical research and the legal, methodological and ethical issues involved in the undertaking of biomedical research (including Good Clinical Practice). It will detail the principles and practical application of statistics in clinical trials and the role and responsibilities of the statistician as part of the R & D team. It will outline the early studies in patients and describe the strategy behind drug development within the pharmaceutical industry and in particular the basis for assessing continuing viability of development projects.

Module 3: PM7014 - Clinical Trials (Term 1)*

Module Overview:

This module provides comprehensive information on the clinical development of new medicines. It describes the choice of clinical trial design and target populations, according to the proposed indication for use. It examines in detail the key issues involved in the conduct of a clinical trial and describes their statistical analysis and reporting. It describes the handling the safety data in clinical trials and how it impacts on drug development. It highlights the importance of evaluation in at-risk populations and explores the concept of benefit / risk assessment in clinical development. The aim of this module is to ensure comprehensive knowledge in the area of clinical development and how the clinical development programme interacts with the overall R & D programme.

* - these modules are run in parallel

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Module 4: PM7012 - Non-Clinical Testing, Pharmaceutical and Early Clinical Development (Term 2)

Module Overview:

The objective of this module is to develop a higher understanding of the types of pharmaceutical and non-clinical testing carried out on new drug substances and how these fit into the overall development programme. It discusses the principles of early pharmaceutical development of drug substance and how the choice of formulation is made with reference to the proposed indication for use. It provides background information on how potential candidates are tested for bioequivalence, stability, impurity and incompatibility in order to produce the final product specification. It describes in detail the different stages of non-clinical (pharmaco-toxicology testing) and how these findings are used to plan early exploratory development in man, as part of the overall R & D plan.

Module 5: PM7022 - Project Management in Medicines Development (Term 2)

Module Overview:

This module provides the student with the opportunity to develop competence in the logistical aspects of R & D (project management). It details how to define, plan, manage and verify the scope of the development of a medicine. It promotes in-depth knowledge of how to identify factors in failing clinical trials and discusses the concept of project rescue.

Module 6: PM7019 - Special Populations: Clinical Trial Practice and Regulation (Term 2)

Module Overview:

This module provides in-depth knowledge into the impact of the specific target population on the undertaking of clinical research. It details the importance of taking physiological profile, disease characteristics into account and provides practical examples of how to conduct clinical research in vulnerable populations. The aim of the module is to enable the student develop competence in the area of clinical research, appropriate to the target patient profile, particularly in vulnerable populations.

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Year 2

Module 7: PM7020 - Medicines Regulation (Term 1)**

Module Overview:

This module, run in parallel with module 8, provides comprehensive information on the role of drug regulation before and during the authorisation of medicines. It details the current national and international regulatory requirements for the authorisation of medicines. It looks at the guidelines which are published to aid new drug development by the various regulatory agencies, and evaluates the importance of practical input from expert international organisations. The aim of the two modules is to enable the student gain competence in the handling of all regulatory lifecycle issues of a medicine both pre- peri- and post-authorisation in the various jurisdictions.

Module 8: PM7015 - Regulatory Affairs; Drug Safety & Pharmacovigilance (Term 1)**

Module Overview:

This module, run in parallel with module 7, provides comprehensive information on the role of drug regulation with a particular emphasis on the regulation of drug safety during and after the authorisation phase of drug development. It details the current national and international requirements for the regulatory aspects of the authorisation of medicines. It details the regulation and management of drug safety issues, both pre-and post-approval. The aim of the two modules is to enable the student gain competence in the handling of all regulatory lifecycle issues of a medicine both pre- peri- and post-authorisation in the various jurisdictions

**These modules will be undertaken by way of blended learning in parallel

Module 9: PM7017 - Drug Safety: Pharmacoepidemiology, Pharmacovigilance and Risk Management (Term 1) §

Module Overview:

This module provides comprehensive information on pharmacovigilance and the existing regulatory requirements for the pharmaceutical industry and regulatory authorities at EU and international level. It explains the principles of pharmacoepidemiology and how these are used to evaluate drug safety in practice. It discusses drug interactions and how they can be avoided; medication errors and their prevention +/- management and provides information on research methodology in pharmacovigilance. The aim of this module is to promote a higher understanding of the benefit/risk evaluation of drugs and the importance of safety monitoring throughout the lifecycle of a medicine.

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Module 10: PM7018 - Biologicals and Advanced Therapies (Term 1) § Module Overview:

This module provides comprehensive information on medicines derived from biological sources, including those defined as advanced therapies. It details the legal, ethical, regulatory and practical issues relating to the development of such medicines and provides practical application of the regulatory provisions. The aim is to enable the student to be able to work as part of a team in the lifecycle management of a biological agent or advanced therapy.

§ - these modules may be run in parallel

Module 11: PM7021 - Health Economics / Pharmacoeconomics (Term 2) #

Module Overview:

The aim of this module is to provide a higher understanding of the importance of health economics in contemporary healthcare management. It will give a comprehensive overview of the principles of health economics, economic modelling, QALY’s and sensitivity analysis. It will provide practical examples of how economic principles are used to measure the cost-effectiveness of medicines and how this impacts on the pharmaceutical industry. Module 12: PM7016 - Healthcare Marketplace; Economics of Healthcare (Term 2) # Module content:

This module focuses on the lifecycle management of medicines. It describes the legal and ethical principles governing communication between the pharmaceutical industry and healthcare professionals and. It examines the provision of product information within the healthcare marketplace by a pharmaceutical company and the role of educational versus promotional activities relating to the use of medicines. It discusses the developing role of health technology assessment within the pharmaceutical arena. The aim of the module is to enable the student to be competent in the management of all aspects of the lifecycle management of a medicine.

# - these modules are run in parallel

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Course Venue

The course will be held in the Trinity Centre for Health Sciences Building at the St. James’s Hospital campus, Dublin 8. Enrolled students will be notified of the exact venue in advance of each module.

Course Materials

Comprehensive course materials will available on Blackboard for each module. In addition, students will be provided with pre-module reading electronically before each of the taught modules. The students will be expected to review all material provided and to study the reading lists contained in the course materials. Personal assignments for each module must be completed by each student and returned within the designated time frame. Late assignments will be subject to penalties.

Students will be expected to provide their own computer and online access for the modules undertaken by distance learning.

Total Fees for 2019/2020*

EU Non-EU € € Diploma fee Year 1 5,778 12,128 Year 2 5,176 10,846

MSc. Year 1 5,778 12,128 Year 2 5,778 12,128

*Fees shown include tuition fees, sports levy, USI levy and commencement fees

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Course Faculty

Head of the Department

Prof. Michael Barry is a Consultant Clinical Pharmacologist and Head of the Department of Pharmacology & Therapeutics at the University of Dublin, Trinity College. He is the clinical director of the National Centre for Pharmacoeconomics which conducts pharmacoeconomic evaluations on medicines prior to reimbursement under the Community Drugs schemes in Ireland. He is Past-President (2010-2011) of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). He was a board member of the Health Information and Quality Authority (HIQA) and is a member of a number of National Committees on pricing and reimbursement of medicines. Prof. Barry chairs the New Drugs Committee and the Medication Safety Committee at St. James’s Hospital, Dublin. In 2013 he was appointed as Clinical Lead for the new HSE Medicines Management Programme. He is a fellow of the Royal College of Physicians in Ireland and is a specialty trainer for Pharmacology & Therapeutics. His research areas include the cost-effectiveness of high cost drugs including chemotherapeutic agents and biologic drugs, pricing and reimbursement and performance based risk sharing schemes. He has published widely on the cost-effectiveness of medicines in the Irish healthcare setting.

Course Director

Dr Mary Teeling is a specialist pharmaceutical physician with over 30 years’ experience in the areas of pharmacology and pharmaceutical medicine. She was part of the development team for the courses in Pharmaceutical Medicine in 2004, while working in Trinity College Dublin, and is currently adjunct assistant professor in the Dept. of Pharmacology and Therapeutics. Prior to working in Trinity College Dublin, Mary worked in the Irish Medicines Board (now Health Products Regulatory Authority) for 12 years and was its medical director for 6 years. She was the Irish member of the EU Committee for Human Medicinal Products (CHMP) in the European Medicines Agency (EMA) and served as its vice-chair for 3 years. She was part of the educational team that developed the higher speciality training (HST) programme in pharmaceutical medicine with the Royal College of Physicians in Ireland. The programme achieved approval from the Medical Council of Ireland in 2016 and she is the current national specialty director (NSD).

Course Co-ordinators

Mary Rafter is responsible for day-to-day running of the courses, since joining Trinity College Dublin as assistant professor in pharmaceutical medicine in 2017. With a background as a pharmacist, she has spent a considerable portion of her career as a pharmaceutical assessor at the Health Products Regulatory Authority (HPRA, formerly Irish Medicines Board), and represented the board on various CPMP/CHMP/EMA committees as a pharmaceutical expert. This was interspersed with periods spent in the pharmaceutical industry, including as senior manager of a global regulatory affairs team at Pfizer Newbridge. She has worked as a consultant in the regulatory affairs arena and contributed to academic education programmes since obtaining her MSc in Pharmaceutical Medicine from Trinity College in 2010.

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Joanne Ramsey is also responsible for the day-to-day running of the courses. Joanne graduated from University of Ulster with a degree in Biomedical Science and obtained her Diploma in Professional Practice (DPP) working in the NHS. She carried out her PhD in the Centre for Cancer Research and Cell Biology at Queen's University Belfast where she studied small molecule therapies in malignant diseases. Upon completion of her PhD in 2011 she took up a pharmaceutical research position in Royal College of Surgeons in Ireland developing ATMPs and is involved in two invention disclosures and one patented gene therapy. She became a lecturer and principal investigator in RCSI in 2015 and obtained her postgraduate diploma in Health Professional’s Education before joining Trinity College Dublin as assistant professor in pharmaceutical medicine in 2019. Course Executive Officer

Geraldine Crowther assists with the administration of the course. [E-mail:[email protected]]

Course Faculty

In addition to the faculty members from the academic staff of the Faculty of Health Sciences, Trinity College, the course will include contributions from experts from the National Centres for Pharmacoeconomics and Medicines Information, and experts from national and international regulatory authorities and pharmaceutical organisations.

mailto:[email protected]

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For Further Information

Contact the Course Co-ordinators (Mary Rafter or Joanne Ramsey) at: [email protected] or [email protected] Phone: 00 353 1 8961568 Fax: 00 353 1 4730596

or

https://www.tcd.ie/medicine/pharmacology-therapeutic/postgraduate

Applications for this course should be made online via:

https://www.tcd.ie/study/apply/index.php




https://www.tcd.ie/medicine/pharmacology-therapeutic/postgraduate

https://www.tcd.ie/study/apply/index.php

Department of Pharmacology and Therapeutics Postgraduate ... · PG Dip/MSc Pharmaceutical Medicine Prospectus 2019 Year 2 Module 7: PM7020 - Medicines Regulation (Term 1)** Module

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